Prospective Assay for SARS-CoV-2 (COVID-19) Antibody Detection Indirectly by Immunofluorescence: SARS-CoV2 IIF Method
NCT ID: NCT04429620
Last Updated: 2020-06-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
100 participants
OBSERVATIONAL
2020-05-30
2020-12-31
Brief Summary
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Detailed Description
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* 100 µl of serum for standard SARS-CoV2 ELISA is used according to the instructions for use.
* 100 µl of serum indirect immunofluorescent (IIF) method is used, the samples thus prepared analysis is performed under an automated microscope
Conditions
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Study Design
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CASE_CONTROL
OTHER
Study Groups
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Positive group
Subjects are diagnosed with SARS-CoV2 by qPCR assay.
Immunfluorescence
Serum indirect immunofluorescent (IIF) method is used, analysis is performed under an automated microscope.
Negative group
Subject were 2 times proved negative SARS-CoV2 by qPCR assay.
Immunfluorescence
Serum indirect immunofluorescent (IIF) method is used, analysis is performed under an automated microscope.
Interventions
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Immunfluorescence
Serum indirect immunofluorescent (IIF) method is used, analysis is performed under an automated microscope.
Eligibility Criteria
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Inclusion Criteria
* Signing a package leaflet and a informal consent
* In the case of a positive group, confirmed by SARS-CoV2 qPCR Patient with COVID-19 or recovered individual.
* In case of negative group by SARS-CoV2 qPCR test 2 negative in COVID-19 suffering individual
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Bilogical Research Centre, Szeged
UNKNOWN
Szeged University
OTHER
Responsible Party
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Principal Investigators
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Katalin Burián, MD
Role: PRINCIPAL_INVESTIGATOR
University of Szeged, Institute of Clinical Microbilogy
Locations
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University of Szeged, Albert Szent-Györgyi Health Center
Szeged, , Hungary
Countries
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Central Contacts
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Dávid Pintér, Pharm. D.
Role: CONTACT
Facility Contacts
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Katalin Burián, MD
Role: primary
Related Links
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COVID-19 situation update worldwide
COVID-19 CORONAVIRUS PANDEMIC
A serological assay to detect SARS-CoV-2 seroconversion in humans
Serological and molecular findings during SARS-CoV-2 infection: the first case study in Finland, January to February 2020
Other Identifiers
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SARS-CoV-2-IIF-002
Identifier Type: -
Identifier Source: org_study_id
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